Supreme Court Seems Ok With Patenting Medical Diagnostics

from the bad,-bad-news dept

We've covered the Mayo v. Promethus Labs case for a while now. This is the lawsuit over the patentability of medical diagnostic techniques. If that sounds crazy to you, you're not alone. Promethius got a patent on a specific way of testing for a disease, and got into a legal fight with the Mayo Clinic, because Mayo dared to diagnose without paying them. Tragically, an appeals court said this was fine. Many doctors were, quite understandably, horrified at all of this. The idea that they could violate a patent merely by understanding the science and running a test to detect an ailment? Horrifying and ridiculous. When the Supreme Court agreed to pick up the case, we had hoped it meant that some common sense might prevail.

However, that's looking doubtful. The oral arguments were just heard in the case, and as Tim Lee points out, they don't sound good. You can read the full transcript below, but the oral discussion was extremely narrowly focused on the patentability of this particular diagnostic test, with many comments suggesting that the patentability of a general diagnostic test is not even in question. In fact, Mayo's own lawyer seemed to concede the point and didn't even bother to argue the issue:

Unfortunately, the justices seemed oblivious to these arguments. And the man who should have been making them, Mayo counsel Stephen Shapiro, completely ignored them. Instead, he seemed to concede the legality of medical patents in general, and focused on nitpicking the details of Prometheus's patent. Specifically, he noted that the patent covers a broad range of metabolite levels and applies for many different autoimmune diseases, and argued that this made the patent invalid.

Asked by Justice Kennedy if a more specific and complex diagnostic technique involving "two or three different drugs" could be eligible for patent protection, Shapiro said yes. "If it leaves room for others to have their own tests with different numbers and different procedures so that it isn't just one test for the whole country, then yes, if it's specific enough," he said. "The specificity is the key."

Justice Scalia pointed out that making patent-eligibility turn on how complex the diagnostic strategy was, or on how many diseases it claimed to address, was totally unworkable. Shapiro's proposal, he said, was "not a patent rule that we could possibly apply."

Justices Scalia and Breyer showed some skepticism that patents could cover the use of scientific correlations in medical practice. But the other justices expressed no such skepticism. At one point, Justice Kagan offered some advice to Prometheus's lawyer. "What you haven't done is say at a certain number you should use a certain treatment, at another number you should use another treatment," she said. "I guess the first question is why didn't you file a patent like that? Because that clearly would have been patentable. Everybody agrees with that."

Except, as Lee notes, not everyone agrees with that. In fact many different groups, including the American Medical Association, argued exactly the opposite in briefs on the case.

For what's it worth, what's discussed in the oral hearing is not always all that relevant to how the case actually turns out. The briefs are often more important. But, either way, it's not looking good. After a few good years in the mid-2000s, where the Supreme Court really beat back patent excesses, the more recent patent courts have been timid to the point of ridiculous. In the end, it seems like this case may turn out like the Bilski case, where the Supreme Court had the opportunity to rule broadly on software and business method patents, but chose to ignore the issue, focusing only on the specific patent in question.

This seems like a huge waste of the Supreme Court's time and collective intellect. People look to SC rulings to set precedent and clarify points of law. Ruling extremely narrowly based on just the specifics of the patent itself doesn't clear up any confusion. Instead, it just makes things worse.

Predicting Supreme Court decisions based on oral arguments is approximately as accurate as predicting stock prices based on tea leaves and chicken entrails.

To be generous, justices often play devil's advocate during oral arguments, and justices who have had their questions answered in briefs may not speak up. To be cynical, I suspect that the law clerks working behind the scenes are often more influential that the oral arguments of the opposing attorneys.

The tenor of the hearing might have been influenced by the fact that the counsel for the Mayo Clinic himself didn't argue against medical patents being invalid. His argument was that this patent was invalid.

The patent wasn't for "a specific way of testing for a disease," and Prometheus isn't the patentee. The method in question is [purportedly] therapeutic, not diagnostic; if you accept Prometheus's interpretation of it, it describes a way to safely administer a dangerous drug without killing your patient. And Prometheus is the exclusive licensee of the alleged invention, not the inventor.

Also, it should be noted that the AMA's brief doesn't oppose the patentability of diagnostic tests or medical devices or processes generally, as you suggest:

Amici medical associations recognize that health-care-related patents can enhance the provision of high-quality and cost-effective medical care. The financial incentive that patents offer supports the expensive and uncertain research required to identify, test, and gain approval for new pharmaceuticals, medical devices, diagnostic testing kits, and other products. In this respect, the patent system has served patients and the medical profession well, drawing investment into the development of important new treatments.

Patents on scientific observations underlying medical care, however, do not have these salutary effects. Such patents erode the quality of patient care by limiting use of the very knowledge on which physicians must rely to diagnose and treat their patients, threaten to stifle innovation and the development of personalized medicine, and raise ethical concerns for physicians.

the failure to sort out more than the one issue at hand keeps these judges in work and in office. whilst they continue to get paid, the more things they have to do to justify them being there, the better off they are!

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the failure to sort out more than the one issue at hand keeps these judges in work and in office. whilst they continue to get paid, the more things they have to do to justify them being there, the better off they are!

How about this: when was the last time you voted for a member of the Supreme Court? Perhaps it would be bad policy to have the least democratic branch of government (i.e., the judiciary) issue broad rulings that have not been voted upon by the public.

The Supreme Court is there to settle disputes and interpret the Constitution, not legislate from the bench. If you want broad change, talk to your Congressman.

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Sorry for the abbreviated flame. What I meant to say is:

(1) The Supreme Court is important precisely for its anti-majoritarian abilities. It's there to interpret the Constitution, and if that means shooting down legislation that's been voted on (by those who were voted in by) the public, then that's exactly what the Court is there to do.

(2) I just have to believe you're kidding about talking to my Congressman.

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(1) The Supreme Court is important precisely for its anti-majoritarian abilities. It's there to interpret the Constitution, and if that means shooting down legislation that's been voted on (by those who were voted in by) the public, then that's exactly what the Court is there to do.

Perhaps, but only if the conflict between the Constitution and the legislation is unavoidable. If SCOTUS can find a way to dispose of the case without having to opine on what the Constitution means, it should.

Realize: every ruling regarding the constitutionality of a law is decided by five justices on the bench. FIVE! If those five justices get it wrong, too bad, so sad, it's now binding precedent for everyone. And that binding precedent can only be overturned by enacting a Constitutional amendment (which is really difficult) or by convincing a different five justices to do so (which requires the right set of circumstances and can take a really long time). Thus, it would be really improper for SCOTUS to start unnecessarily creating binding precedent in the name of the Constitution when it does not have to.

(2) I just have to believe you're kidding about talking to my Congressman.

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You and I definitely don't disagree about the force those 9 people pack--but we disagree about whether they should. What's truly too bad/so sad is that there is no longer any actual discussion between the 9 about what a right result may be--those are pre-determined by politics now. And yes, maybe they always have been, but minds used to change in chambers--I swear--and now they just flat-out don't. Maybe one does, and he's the swing vote in any swingable case.

Reform legislation occurs, at times, as a reaction to Supreme Court rulings. But it alwsys occurs in the course of back-room dealings where Congresspeople give up something they pretend to oppose fervently in exchange for something they want that will help them keep their jobs. Just like all other legislation.

Mike, all cases that go to the SC basically are settling narrow disputes. Some of those rulings do provide guidance for other similar cases, especially when they address situations that have broad implications (Roe V Wade, example).

In this case, I think the SC is pretty much seems to be siding with the AMA, which seems to draw a nice line between scientific observation and actual application in technology. It seems like a pretty good way to look at things.

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Because patent lawyers are not in the business of rendering anything unpatentable

Just to be clear, Mayo was arguing here that certain things should be unpatentable. And one of the lawyers whose name is on Mayo's brief is a registered Patent Attorney employed by Mayo. So for the record, at least one patent lawyer was trying to "render[] [some]thing unpatentable" here.

More generally, though, patent counsel representing the defendants in infringement suits make their very livings trying to render things unpatentable.

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Sorry to pile on, but this is just stupid. Any patent attorney defending a client against a claim of infringement will likely seek to invalidate the plaintiff's patent--a/k/a, "render[] it unpatentable."

The SC has to act within the bounds of the patent laws as passed by Congress. They interpret the law, and can establish doctrines as is done in common law so long as those don't outright conflict with the statutes that have been passed. Part of the problem is that many of the issues we face now weren't around when the patent laws were written, and the SC is limited in how they can approach it. They can't rewrite the patent statutes just because they feel like it.

The way it 'should' work on something like this is that Congress says 'hey, this is crazy' and steps in and amends the patent laws to take these new situations into account and provide the correct result.

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This is wrong. The Supreme Court is the grand interpreter of the Constitution--specifically, of that document's interaction with legislation. So the Court doesn't have to "act within the bounds of the patent laws as passed by Congress," since it can rule any of those laws unconstitutional. Also, since Congress's ability to grant limited monopolies in the IP realm stems from the Constitution, that places IP law firmly within the ambit of the Court.

Check out the Court's look at the Mickey Mouse Copyright Extension Act for evidence that the SCt can pass on the constitutionality of IP law.

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Article I, section 8
"To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries;"

Unless the patent law exceeds the scope of that power, or runs afoul of another constitutional provision then the supreme court can't chuck it out. They will be limited to interpreting the statutory provision, and making good faith extensions that are consistent with the statute.

Bad laws that are consistent with the constitution can be fixed in one place only.

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You just contradicted yourself. You said first that the SCt has to act within the bounds of patent law as passed by Congress. Then you said that the Court can exceed that power because of its constitutional mandate under exactly the section you quote. It also has that power under stare decisis.

So you were wrong the first time, and you're wrong the second time, too, and twice there as well. Your statement that the Court is limited to "making good faith extensions" to laws in any case is just nonsensical. The Court can curtail a law, can kill it in its entirety, and can also rule on a case without holding forth on the constitutionality of a law one way or the other. In other words, the SCt can be the final arbiter of the facts in a case and what result must follow, period. The Court also has the option of upholding a law by not ruling on it at all--action through in action. Oh, and a third thing: bad laws that are consistent with the constitution can be fixed in one place only is wrong, too: Congress can change them; the relevant enforcer can refuse to enforce them, including the President, referenda can be held, and on and on.

Generally patents were intended to cover a specific invention that performed a specific function. The intention was to provide the inventor(s) with a small time period in which they enjoyed a monopoly over that invention.
The idea was that by granting patents one would reduce the number of trade secrets and open up general knowledge in the field.
I don't know that any of that is arguable. It ought not to be.
Patent law has extended itself, like a cancer, to include process which isn't a physical manifestion of anything nor does it lead to a product in the physical world. All these patents do is lead to walling up knowledge and it's application which is the polar opposite of what patents are or, at least, were the intention of patents.
My problem with patenting any kind of diagnositc technique or process is that all diagnostics are, in some small form or other, different. What appears, on the surface, to be the same presenting problem, can often turn out to be something entirely different than what process and past experience says it ought to be. This applies to trouble shooting as much as it applies to a medical diagnosis though the outcomes in medicine are far more important, in the vast majority of cases, than me diagnosing and repairing a telecom transmission problem.
Should a patent interfere with the doctor taking her were she needs to go on what I present.then the patent system has failed. A GP ought not to have to fire a full time patent lawyer to make sure ever diagnosis she makes doesn't violate some obsure diagnostic process that's some obscure pharma company or patent troll. Instead of opening knowledge these process patents build walled gardens around it.
If, as Promethius claims, their patented instructions only deal with how to determine to dosage so that the patient isn't accidentally overdosed then fine. But if the Mayo Clinic come up with an alternative they wish to share then don't drag 'em to court. You're still gonna sell your blasted drug so sit back and gather the money in. Who knows, a diagnostic regime backed by the Mayo Clinic would, more than likely, INCREASE sales.
We've seen similar instances happen in software where companies and associations stock patents up not because they need them but as much to defend themselves from patent trolls and the odd occasional legitimate patent complaint. The latter is so odd that it's as rare as hen's teeth. Most of them are overturned due to prior art or another reason after research is done by the readers of this site or Groklaw.
In sum, I'm forced to ask "just WHAT is being accomplished here"? In terms of this sort of thing and software patents I strongly suggest nothing that has to do with the original stated purpose of patents to begin with. That is to end trade secrets in order to expand knowledge. Instead, we are getting walled gardens.
Will the Supreme Court of the United States deal with the broader issues raised in this case? I don't know. Written briefs carry as much weight as oral ones do, in theory, and the Mayo Clinic's lawyers may have felt that it would he easier and more probable that they could overturn this patent by itself rather than the more difficult issue of diagnostic process patents in general and process patents in general.
It's sad when the patent process creates the very same issues it was designed to prevent.

Saddened but hardly surprised by this.

Really, it's all downhill from here. America is a fascist nation that actually has its politicians stand up in Congress and claim that the nation is a terrorist warzone and that they need to be able to lock citizens up without any due process - and the President may veto it, because it doesn't give him enough powers to lock people up...

This patent hysteria and doing these things that are so wildly against any kind of common sense isn't going to stop until we make it stop, and it's going to take the total redesign of society into one that uses the scientific method to address social concerns - not the say-so of bought and paid for crooks in Congress and the Supreme Court.

You can't really spin this particular case in any way to make it good for anybody in the real world, and it's not the first case or even necessarily the most egregious - the entire way of thinking that this exposes is a sign of a sick, sick society.

This seems like a huge waste of the Supreme Court's time and collective intellect. People look to SC rulings to set precedent and clarify points of law. Ruling extremely narrowly based on just the specifics of the patent itself doesn't clear up any confusion. Instead, it just makes things worse.

Does anyone recall when we worried more about the constitutionality of a law than it's setting of precedence and meaning?

another biased article

They sell blog filler and "insights" to major corporations including MS, HP, IBM etc. who just happen to be some of the world’s most frequent patent suit defendants. Obviously, he has failed to report his conflicts as any reputable reporter would. But then Masnick and his monkeys are not reporters. They are patent system saboteurs receiving funding from huge corporate infringers. They cannot be trusted and have no credibility. All they know about patents is they don’t have any.

Scalia is right, but is missing the point.

"Justice Scalia pointed out that making patent-eligibility turn on how complex the diagnostic strategy was, or on how many diseases it claimed to address, was totally unworkable. Shapiro's proposal, he said, was "not a patent rule that we could possibly apply." "

The law is not about complexity, but on weather such an application is obvious to a person skilled in the art. Would a doctor reasonably skilled in the arts of diagnostics be likely the know how to apply this natural correlation. (which is in itself clearly not patent-able. A patent which does not increase the amount of public knowledge available for a field of endeavor should never be granted, it's simply not in the public interest to do so.

Things that are less complex a more likely to be obvious, and those more complex, less so.